| CTRI Number |
CTRI/2021/12/038803 [Registered on: 21/12/2021] Trial Registered Prospectively |
| Last Modified On: |
03/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Effect of hand squeezing a ball on pain during insertion of intravenous cannula] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of hand squeezing a ball in reducing pain in a child due to intravenous cannulation |
|
Scientific Title of Study
|
A study to assess the effect of hand squeezing a ball on pain during insertion of intravenous cannula among children posted for ophthalmic surgeries in a tertiary care hospital, New Delhi: A randomized controlled trial |
| Trial Acronym |
HSBRP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
TThuileiphy Tallanao |
| Designation |
Nursing Officer |
| Affiliation |
AIIMS, New Delhi |
| Address |
Ward 4BPHDU/, 4th floor, Dr. Rajendra Prasad Centre for Ophthalmic sciences, AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9990296932 |
| Fax |
|
| Email |
tulip10986@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Joshi |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 2, Porta Cabin, College of Nursing, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9818039744 |
| Fax |
|
| Email |
pjoshi495@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poonam Joshi |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 2, Porta Cabin, College of Nursing, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9818039744 |
| Fax |
|
| Email |
pjoshi495@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Rajendra Prasad Centre for Ophthalmic Sciences AIIMS, New Delhi |
|
|
Primary Sponsor
|
| Name |
T Thuileiphy Tallanao |
| Address |
Ward 4B/PHDU, 4th floor, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| T Thuileiphy Tallanao |
AIIMS, New Delhi |
Ward 4B/PHDU, 4th floor, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi
South
DELHI |
9990296932
tulip10986@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C69||Malignant neoplasm of eye and adnexa, (2) ICD-10 Condition: C698||Malignant neoplasm of overlappingsites of eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hand squeezing ball on pain during the insertion of IV cannula |
squeezing the toy for 10 to 15 times on hand not used for cannulation |
| Comparator Agent |
Standard of care (reassurance) |
reassurance |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children admitted in the hospital within the age group of 4-12 years.
2. Undergoing IV cannulation.
3. Whose caregivers are willing to consent for the participation of children in the study
|
|
| ExclusionCriteria |
| Details |
1. Chronically ill child.
2. Mentally challenged.
3. Child with sensory/ musculoskeletal problems.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain |
immediately after the cannulation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No secondary outcome |
0 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A study to assess the effect of hand squeezing a ball on pain during insertion of intravenous cannula among children posted for ophthalmic surgeries in a tertiary care hospital, New Delhi: A randomized controlled trial -[HSBRP]
in an open labelled study, the children between 4 to 12 years will be enrolled. The recruitment process has not yet started. There is plan to start enrolment from the 27th September 2021. |